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Ketogenic Dietary Intervention in Men With Mild-to-Moderate COPD
Sponsor: Agri Ibrahim Cecen University
Summary
Chronic obstructive pulmonary disease (COPD) is associated with persistent airflow limitation, systemic inflammation, reduced exercise capacity, and unfavorable changes in body composition. Nutritional interventions may represent a complementary strategy to improve clinical outcomes in individuals with COPD. This pilot randomized controlled trial evaluates the feasibility, safety, and preliminary effectiveness of an 8-week ketogenic dietary intervention in men with mild-to-moderate COPD. Participants are randomly assigned to either a supervised ketogenic diet or a control group receiving standard dietary advice. The ketogenic diet restricts carbohydrate intake and promotes nutritional ketosis, which is monitored using blood beta-hydroxybutyrate measurements. The primary outcome is change in the FEV1/FVC ratio. Secondary outcomes include systemic inflammation assessed by C-reactive protein (CRP), phase angle measured by bioelectrical impedance analysis, functional exercise capacity assessed by the 6-minute walk test, estimated aerobic capacity, body composition, and selected biochemical safety markers. The study aims to provide preliminary evidence regarding whether a ketogenic dietary approach may improve inflammatory status, functional capacity, and physiological outcomes in individuals with COPD.
Official title: Effects of an 8-Week Ketogenic Dietary Intervention on Pulmonary Function, Systemic Inflammation, Body Composition, and Functional Exercise Capacity in Men With Mild-to-Moderate Chronic Obstructive Pulmonary Disease: A Pilot Randomized Controlled Trial
Key Details
Gender
MALE
Age Range
40 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
34
Start Date
2025-08-15
Completion Date
2026-06-15
Last Updated
2026-06-23
Healthy Volunteers
No
Interventions
Ketogenic diet
Participants received an individualized ketogenic dietary intervention for 8 weeks. The dietary prescription provided approximately 60-70% of total energy from fat, 15-20% from protein, and 5-10% from carbohydrates, with carbohydrate intake restricted to less than 50 g/day. Nutritional ketosis was monitored using blood beta-hydroxybutyrate measurements throughout the intervention period.
Standard Dietary Advice
Participants received standard dietary recommendations for chronic obstructive pulmonary disease and were instructed to maintain their habitual dietary patterns during the 8-week study period.
Locations (1)
Ağrı İbrahim Çeçen University
Ağrı, Turkey (Türkiye)